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A Study to Explore Signs, Symptoms, and Biomarkers in Dry Eye Disease Participants Following Anti-inflammatory Treatment
Eye Disorder Dry eye syndrome
Basic Details
Study Summary
This study aims to evaluate the performance of biomarkers and their responsiveness to standard-of-care treatments (Vevye® or Xiidra®), in participants with dry eye disease (DED) compared to healthy volunteers (control participants).
Eligibility Criteria
A. Inclusion Criteria for Participants with DED:
- The participant reported dry eye-related ocular symptoms for at least 6 months before the screening visit
- The participant must have either used lubricant eye drops regularly OR had the desire to use lubricant eye drops in the past 3 months
- Participant must be classified as having moderate/severe DED
- The participant is deemed by the physician to require a prescription medication for DED (e.g., cyclosporin A or lifitegrast)
B. Inclusion Criteria for Healthy Volunteers:
- The participant does not have overt clinical signs of DED in either eye
- Intraocular pressure (IOP) >21.00 millimeters of mercury (mmHg) in either eye
- Acute allergic conjunctivitis in either eye within 3 months prior to screening
- Use of contact lenses within 30 days prior to screening
- Current punctal plugs or punctal cauterization or occlusion
- Use of ocular anti-inflammatory agents or ocular immunosuppressive agents within 3 months prior to screening
- Any intraocular injections (e.g., intravitreal [IVT] anti-vascular endothelial growth factor [VEGF]) within 3 months prior to screening, or such injections planned for within the study period
- Any intraocular immunosuppressive implants within 12 months prior to screening
- Any history of isotretinoin use within 12 months prior to screening
- Uncontrolled ocular or systemic disease
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com